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Process Engineer

$85k - $110k

STAAR Surgical

Job TitleMAIN JOB RESPONSIBILITIES / COMPETENCIESIn support of the manufacture of STAAR products:Provide assistance in troubleshooting/resolving day to day manufacturing issuesIdentify, source, and pilot new equipment to support process improvements in manufacturingCreate and execute validation protocols (IQ, OQ, PQ) and summarize test results as requiredCreate and execute Test Method Validations (TMV) on measurement equipmentOptimize process flow and eliminate non-value added steps in product handling; increase efficiencies; and reduce product lead time to Finished Goods Inventory.Support and lead manufacturing design transfer activities for new products being introduced to productionConduct root cause analysis for issues found in productionSupport open non-conforming material reports and CAPAsLiaise with relevant partners in order to drive continuous improvements in manufacturingLead facilities update projects to support manufacturingReview and approve process and engineering documents on behalf of OperationsOther duties as assignedREQUIREMENTSEDUCATION & TRAININGBachelor's degree in technical discipline or equivalent combination of education/experience. Master's degree in a technical discipline a plus. Lean/Six Sigma or similar training a plusEXPERIENCEMinimum of 5 years experience in a regulated industry. Design transfer experience preferred. Clean room operations experience a strong plus. Design experience using CAD or related software preferred.SKILLSDemonstrated understanding of, and ability to practically implement, cGMP/QSR/ISO requirements. Excellent team building and interpersonal skills. Excellent prioritization, multi-tasking and organizational skills. Ability to lead cross-functional teams to execute projects to planned timeline. Well versed in lean manufacturing and process improvement. Working knowledge of requirements around IOL's or other Class III medical devicesPay range: $85-$110k Final compensation/salary will be depend on experience STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law. #USA

Vacancy posted 1 day ago
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